ADDITIVE MANUFACTURING FOR

MEDICAL TECHNOLOGY
AN OVERVIEW OF THE ADDITIVE MANUFACTURING MARKET
AND ITS ROLE ON THE ADVANCES IN MEDICAL, BIOPRINTING
AND DRUG DISCOVERY
 CONTENTS ADDITIVE MANUFACTURING FOR
Introduction MEDICAL TECHNOLOGY
Executive Summary
Market Overview Additive Manufacturing techniques offer great potential to
Key Benefits of medical technology manufacturers a market forecast to grow in
implementing additive value to $10.8 billion by 2021.
manufacturing into the
development process This report provides an overview of the global additive
Main challenges of additive manufacturing sector, covering the advantages it offers to medical
manufacturing technology providers, recent innovations in 3D printing and the
Innovation in 3D printing challenges and opportunities it presents.

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EXECUTIVE SUMMARY

A The adoption of
dditive manufacturing is one of the fastest growing markets
around the world. It is predicted that the market will achieve the
value of up to $10.8 billion by 2021. 3D printing offers
These techniques are effective and are widely used in various industries.
manufacturers a multitude
The three sectors providing the most rapid growth and adoption of 3D of advantages, especially
printing are: Automobile, Consumer Electronics and Medical.
when it comes to cost
It was first used within the medical field in 2000 when the worlds first savings and optimisation of
polymer-based parts and products were printed in a three-dimensional
form.
product design.
The adoption of 3D printing offers manufacturers a multitude of
advantages, especially when it comes to cost savings and optimisation
of product design. Some of the key benefits of additive manufacturing
are:

Shorter supply chains and decreased lead time

Complexity and variety of a 3D printed part or product
Optimised design
Precise customisation

However, some crucial challenges continue to confront the market

players, these include:

The cost and availability of materials

Sustainability of materials
Machine costs
Speed of high-volume production
Quality and reliability
Lack of standards
Business funding challenges

Despite these factors somewhat hindering the development of 3D

printing, the level of innovation in this area is increasing every year. This
is particularly true for regenerative medicine and tissue engineering
disciplines, where we see the greatest advances.

Additive manufacturing has great potential to change the way medical

products and components are being developed and produced. It
is important for Medtech manufacturers to learn more about the
extraordinary possibilities the method offers to the medical world.

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MARKET OVERVIEW

Additive manufacturing, also known as 3D

printing and rapid prototyping, is an automatic
process used to create rapid prototypes
and functional end-use parts. It takes virtual
designs from Computer Aided Design (CAD)
software, and transforms them into thin,
virtual, horizontal layer-wise cross-sections,
until the model is complete.

According to a report published in 2012

by Wohlers Associates, a leading additive
manufacturing research agency, the US
dominates the market with an overall share of
38% with Europe following closely behind with
22%. The adoption of 3D printing technologies
is also gaining momentum in the emerging
markets (Figure 1).
Figure 1: Global share of the additive manufacturing
market (Source: Wohlers Report, 2012)
As for the projected market value, Wohlers Associates predict that,
based on the current worldwide value of approximately $4 billion, the Based on the current
additive manufacturing market is likely to reach $6 billion in 2017 and up
to $10.8 billion by 2021.
worldwide value of
approximately $4 billion,
The key market players are: 3D Systems Corporation (U.S.), 3T RPD
(U.K.), Arcam AB (Sweden), Biomedical Modeling, Inc. (U.S.), Envisiontec
the additive manufacturing
GmbH (Germany), EOS GmbH Electro Optical Systems (Germany), market is likely to reach
Fcubic AB (Sweden), GPI Prototype and Manufacturing Services, Inc.
(U.S.), Greatbatch, Inc. (U.S.), Layerwise NV (Belgium), Limacorporate $6 billion in 2017 and up to
SPA (Italy), Materialise NV (Belgium), Medical Modeling, Inc. (U.S.), and $10.8 billion by 2021.
others.

According to a survey by Wohlers Associates, the total market size for

3D printing products and services across all industries is around $2
billion, almost evenly split between products and services in 2013. The
compound annual growth rate (CAGR) of overall additive manufacturing
industry revenue has been about 25% per year for the last 25 years. The
approximate share of 2013 revenues by industry sector can be seen in
Figure 2 below.

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Based on this chart, it becomes clear that with
a 16% share the medical sector is one of the key
Revenue split of additive manufacturing
equipment customers
industries where 3D printing technologies are
being widely applied. The key difference between
Medical, Automobile and Consumer Electronics 3%
4%
sectors, which outgrow Medical in terms of market
share, is that the medical industry uses additive 16%
manufacturing for direct production of products, 13 %

while the others use it primarily for prototyping.

Medical
One of the key areas which experiences the most Automobile
significant growth is medical implants. Global Academic
Military
Industry Analysts suggests that the international Aerospace
market for orthopaedic instrumentation is 21%
Consumer Electronics
expected to reach about $56 billion by 2017. Industrial
According to some industry estimates, in the near 21% Architectural
future 80% of global implants will be made using Other

additive manufacturing techniques.

Within the medical industry, additive

7%
manufacturing is also widely used in the
10% 5%
manufacturing of surgical equipment, customised
prosthetics and scaffolds, with surgical equipments
accounting for the largest share in this market due
to their wide applicability. Figure 2: Industrial split of Additive Manufacturing
equipment customers (Source: Wohlers Report, 2013)

The success of 3D printing in the medical and biomedical sectors also According to some
contributes to its great innovation potential. Recent discoveries owed
to the development of additive manufacturing technologies include the industry estimates, in
ability to create replacement tissues and blood vessels. Bioprinting, or the near future 80% of
printing fully-functional human organs, is the next step.
global implants will
These recent advances present various exciting opportunities for already be made using additive
established major businesses as well as entrepreneurs. Companies like
Arcam AB, Stratasys, POM Group, Kennametal Stellite, and many others manufacturing techniques
are already exploring biomedical applications of 3D printing. In addition,
a large number of research establishments are also working towards
the development of innovative medical technologies using additive
manufacturing.

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Looking at the historical progress of additive manufacturing and its Figure 3: (Source: Additive manufacturing:
opportunities and constraints by Royal Academy of
future prospects, the developments in 3D printing techniques have come Engineering, 2013)
a long way and have yet much more to offer over the next fifteen years
(Figure 3). There are some major
New and improved technologies, financial support from governments,
challenges AM market is
large application area, rapid product development at a low cost, ease facing, such as regulatory
of development for custom products and a large R&D base are all
considered to be major drivers that are contributing to the rapid growth hurdles, material
of the additive manufacturing market. However, there are also some characterisation during
major challenges this lucrative market is facing, such as regulatory
hurdles, material characterisation during the development stage, as the development stage,
well as sufficient understanding of the techniques and their successful as well as sufficient
adoption into the manufacturing processes.
understanding of the
techniques and their
successful adoption
into the manufacturing
processes.

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KEY BENEFITS OF IMPLEMENTING
ADDITIVE MANUFACTURING INTO
THE DEVELOPMENT PROCESS

A Where a traditional
part from the obvious benefits of being able to consistently
produce customised products (personalised medicine),
and achieve low-volume and low-cost production, additive manufacturing process
manufacturing boasts the following:
would take on average 2
1. Shorter supply chains and decreased lead time weeks, the use of additive
Additive manufacturing is capable of significantly shortening and
simplifying the manufacturing supply chain. This is especially true
manufacturing decreases
when manufacturing takes place on site, eliminating the need for the lead time to as little
transportation and international shipping. This technology has the
potential to bring manufacturers closer to consumers, reducing the
as 48 hours.
links in the supply chain minimising disruptions. Where a traditional
manufacturing process would take on average 2 weeks, the use of
additive manufacturing decreases the lead time to as little as 48 hours.
For example, engineers can create a prototype using a 3D printer directly
after finishing the parts stereo lithography (STL) file. As soon as the part
is printed, engineers may start testing its properties right away.

2. Complexity and variety of a 3D printed part or product

It is quite a paradox, but in fact it costs less to print a more complex
part. The more complex (or, the less solid the object is), the faster and
cheaper it can be made through additive manufacturing. When it comes
to traditional manufacturing, the reverse is true. As for the variety, if the
part being printed needs any alterations, the change can be easily and
quickly made on the original CAD file, allowing for a new, altered product
that can be printed straight away. With the exception of the design cost,
each product produced can be customised at little or no expense.

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3. Optimised design 3D printing plays a crucial
There are few constraints in terms of product design when it comes to
additive manufacturing, you can literally make anything you want using role in personalisation of
CAD software. Additive manufacturing creates latticed designs, which
are impact-absorbing. Lattices also warrant the production of much
medical products, evolving
lighter components, offering economic and environmental benefits. from mass production to
There is also very little waste because only the materials needed are
used.
mass individualisation.
Additive manufacturing enables the creation of more complex
geometries and items that contain multiple moving parts, such as
hinges and bicycle chains for instance. These can be printed using metal
for direct use on the product, which can significantly reduce the part
numbers and create savings in assembly and maintenance.

4. Precise customisation
There is an increasing need for custom-made products in the medical
sector. 3D printing plays a crucial role in personalisation of medical
products, evolving from mass production to mass individualisation.
Additive manufacturing has a wide range of medical applications, and is
extremely important to reconstructive surgery. 3D printing is widely used
for the development of products ranging from dental implants to heart
valves and joint replacements.

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MAIN CHALLENGES OF ADDITIVE
MANUFACTURING

A The increasing machine

dditive manufacturing is hampered by a number of technological
issues and suffers from the lack of a supportive framework,
underfunding and industry standards. costs are still considered
Materials
to be a major factor.
Additive manufacturing allows for product production to use less High-quality additive
material (most commonly plastics and metal), simultaneously sustaining
appropriate level of performance. However, the cost of materials for
manufacturing machines
additive manufacturing can often exceed traditional methods, costing on can cost anywhere from
average $100 to $150 per pound.
$300,000 to $1.5 million.
Also, while metals used for 3D printing are often recyclable, polymers
quite often are not. This poses significant sustainability issues.
There is also a challenge in sourcing new materials, especially in relation
to future 3D printing innovation. Apart from technological limitation,
one of the main reasons why 3D printing cannot be currently used for
the regeneration of complex tissues and organs, is the unavailability of
appropriate biocompatible materials to enable this progress.

Machine Costs
In addition, machine cost is one of the most significant expenses involved
in additive manufacturing. There is, however, a difference between
polymer-based systems and metal-based systems, with the latter being
more expensive. Nonetheless, the increasing machine costs are still
considered to be a major factor. High-quality additive manufacturing
machines can cost anywhere from $300,000 to $1.5 million.

Speed
One of the main competitive advantages traditional manufacturing has
over additive manufacturing is the speed of production. If you compare
low-volume production using additive manufacturing techniques, it
is faster than conventional manufacturing. But higher volumes are
also significantly slower, and 3D printers simply cannot compete with
injection moulding and casting machines when it comes to the speed
of high-volume manufacturing. One possible solution would be to make
parts in parallel production (side by side in the machine), which would
considerably speed up the process.

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Quality and Reliability Despite the significant
Another concern is quality assurance. Currently, there is a need for
standard methods to evaluate and ensure accuracy, surface finish, and uptake in additive
feature detail to achieve the desired part quality.
Significant advances are required in process control and reliability as this
manufacturing and the
can undermine quality of the parts produced by additive manufacturing numerous benefits it
methods. Examples are dimensional and form errors, unwanted voids
in the fused layers, high residual stress in the final parts, and poorly
creates, the government
understood material properties such as hardness and strength. is not particularly
Standards
enthusiastic about funding
There is a need for a defined set of standards to support innovative existing companies to get
advancements. While there are a number of principles already approved,
further development of standards should provide final products with into AM.
a greater degree of traceable properties, procedures, qualified input
materials and confirmed correct processing. All of which can be reported
through online monitoring.

Business Funding
Despite the significant uptake in additive manufacturing and the
numerous benefits it creates, the government is not particularly
enthusiastic about funding existing companies to get into additive
manufacturing. A similar unwillingness can be observed among banks
that appear reluctant to risk investing in manufacturing SMEs wishing
to adopt additive manufacturing. There is, however, an opportunity to
secure the necessary funding from venture capitalists.

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INNOVATION IN 3D PRINTING

T
he current development of 3D printing technologies for
use within the medical sector are related to bioprinting,
or organ-printing. It is no wonder regenerative medicine
and reconstructive surgery are at the forefront of 3D printing
innovation. We have come a long way since 2005 when additive
manufacturing was first introduced into the medical world, and
a mere thought of whats to come is simply mind-blowing.

Artificial skull
In 2013 additive manufacturing made history when a unique
surgery was performed on a female patient replacing an entire
top section of her skull with a 3D printed plastic implant.
Neurosurgeons from the University Medical Centre Utrecht,
Netherlands, performed the extreme procedure to save the
woman from a rare chronic bone disorder, which put her at risk
of permanent brain damage (You can watch a video here).

As with many 3D-printed prosthetics, the skull was customised

to exactly match the patients specific biological and anatomical
characteristics. The surgery was a huge success and the 3D
printed skullcap enabled the patient to regain full eyesight that
was originally damaged by the disease. The surgeons are now
hopeful of using similar medical interventions to help patients
with a variety of other bone disorders. Alternatively, 3D-printed
bones could repair severely damaged skulls after an accident or
tumour.

Artificial ear It is no wonder

Also in 2013, Cornell University scientists created an artificial outer ear
built using 3D printing technology. The prototype was made from living
regenerative medicine and
cells, specifically cartilage samples harvested from cows. In practice, the reconstructive surgery
scientist can just as successfully use cells from cartilage tissue harvested
from a patients ribcage.
are at the forefront of 3D
printing innovation.
Their product is designed to help children born with congenital defects
that leave them with underdeveloped outer ears, such as microtia.

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Artificial skin In 2014, a San Diego
In the meantime, scientists at Wake Forest Institute of Regenerative
Medicine have developed a way to print skin cells directly onto burn company named Organovo
wounds.
announced its intention to
Printer ink is equivalent to skin cells that are taken from undamaged areas attempt printing a human
of the patients skin. A scanner is used to determine wound size and depth
as well as skin cell types found at different points. This information allows
liver.
the printer to apply layers of the correct type of cells to cover the wound.
Only a single patch of skin is required (as little as one-tenth the size of the
burn) to grow enough skin cells for skin printing.

In Europe, a Dutch company called SkinPrint is also working with 3D printers

to treat burn wounds. Instead of printing cells directly onto the patients
wounds SkinPrint are working to create universal transplantable skin grafts.

Artificial liver
In 2014, a San Diego company named Organovo announced its intention
to attempt printing a human liver. The artificial organ would be used only
in a lab for drug research it wouldnt be suitable to implant in a human,
at least not just yet. Organovo has already succeeded in printing its first 3D
liver tissue. Based on the Organovo press release from November 2014, the
company announced the full commercial release of the exVive3DTM Human
Liver Tissue for preclinical drug discovery testing. They are also developing
bioprinted breast cancer tissues alongside lung and muscle tissues.

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Artificial heart
Rather optimistic scientists from
the Cardiovascular Innovation
Institute in Louisville, Kentucky,
are working on a project to
print a fully functional human
heart initially entitled bioficial
heart, which would be made
up from a mixture of natural and
artificial materials. They estimate
the prototype to be finished in
another three to five years, and for
the bioficial heart to be tested on
humans in less than a decade.

The concept involves harvesting

cells from the patients fat, by
removing the fat tissue and
isolating the regenerative cells
contained within it. The cells would Bioprinting has the
then be imported into a bioprinter and mixed with other solutions to print
the heart.
potential to revolutionise
medicine and healthcare
It is clear the project is very complex and will take many years to be
completed. The biggest challenge lies in keeping the printed tissue alive.
beyond what seemed
Another important consideration is for the cells to work together as they possible even 20 years ago
would normally.

With the technology advancing at such a fast rate, bioprinting has the
potential to revolutionise medicine and healthcare beyond what seemed
possible even 20 years ago. Entire organs and bodies produced by
3D printers is becoming a certain reality, rather than a futuristic and
unattainable concept. n

Further information on bioprinting process can be found here:

Youtube Link 1
Youtube Link 2
Youtube Link 3

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